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Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus Type 2

Intervention: ER niacin/laropiprant (Drug); Comparator : placebo (unspecified) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 36 Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant in Patients With Type 2 Diabetes

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo

Secondary outcome:

Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo

Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients between the ages of 18 to 80 years with Type 2 Diabetes who are on a stable

dose of antidiabetic medication for at least 3 months Exclusion Criteria:

- Patients taking Cholestin, niacin (>50 mg/day), fibrate therapy, hormonal

contraceptives, intermittent Hormone Replacement Therapy, or certain corticosteroids

- Patients with any of the following conditions: active liver disease or kidney

disease, poorly controlled high blood pressure, active peptic ulcer, or other heart or blood diseases

- Patients with abnormal laboratory results from a blood test that will be given before

starting the study

Locations and Contacts

Additional Information

(MedWatch - FDA maintained medical product safety Information)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: July 2007
Last updated: February 4, 2015

Page last updated: August 23, 2015

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